FDA product code HNI: Retractor, Ophthalmic
HNI is the FDA product code for retractor, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HNI, from 2 different applicants. The average 510(k) review took 96 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Retractor, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HNI clearance
Top HNI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 1 | 1999-11-02 |
| Concept, Inc. | 1 | 1977-02-17 |
Most recent HNI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991592 | KARL STORZ Endoscopy-America, Inc. | KSEA DE LA PLAZA BLEPHAROPLASTY SET | 1999-11-02 | 179 |
| K770222 | Concept, Inc. | IRIS RETRACTOR | 1977-02-17 | 14 |
Recalls for HNI devices
openFDA lists no recalls for product code HNI.
Frequently asked questions
What is FDA product code HNI?
HNI is the FDA product code for retractor, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNI?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNI?
Across 2 cleared submissions the average was 96 days from receipt to decision (median 96).
Which companies have the most HNI clearances?
KARL STORZ Endoscopy-America, Inc. (1); Concept, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HNI
- Run a recall and safety report across every HNI manufacturer
- Watch product code HNI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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